By Chris Wack
Inhibrx Inc. shares were up 33% to $26.85 after the company said that based on discussions with the U.S. Food and Drug Administration, there is potential to pursue an accelerated approval in the U.S. for INBRX-101.
The stock closed Monday up 12%, and is up 132% in the last three months.
INBRX-101 is an optimized recombinant human AAT-Fc fusion protein for patients with emphysema due to alpha-1 antitrypsin deficiency using functional alpha-1 antitrypsin serum levels as the surrogate endpoint.
Inhibrx also said it detected INBRX-101 in the bronchoalveolar lavage fluid samples from all alpha-1 antitrypsin deficiency patients tested in the Phase 1 study.
The company said it plans to initiate in the first quarter of 2023 a potential registration-enabling clinical trial using functional AAT as a surrogate endpoint with the intent to submit for regulatory approval under the FDA's accelerated approval program. The FDA expressed support to collaborate and work with Inhibrx to address the regulatory challenges associated with AATD drug development, the company said.
It said the FDA emphasized the importance of being able to demonstrate INBRX-101's ability to maintain a trough level within the normal range of AAT in healthy individuals.
The FDA also requested additional data on the correlation between functional AAT levels and the clinical benefit in AATD to further support serum AAT levels as a surrogate endpoint that is reasonably likely to predict clinical benefit, the prerequisite for accelerated approval, Inhibrx said.
On Monday, the company amended the milestone terms of the last remaining tranche under its loan and security agreement with Oxford Finance LLC to provide for the funding of $30 million upon the announcement of the regulatory path for INBRX-101 rather than upon the initiation of a potential registration-enabling clinical trial of INBRX-101. The company has 30 days from this announcement to initiate this draw.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires